Fortrea

Clinical Research

• Provide a high standard of care for participants in clinical trials
• Respond to emergency situations according to clinical research standards
• Monitor clinical study sites, including routine monitoring and close-out visits
• Maintain study files and conduct pre-study and initiation visits
• Liaise with vendors
• Manage sites according to project plans
• Ensure study staff receive proper materials and instructions
• Verify informed consent procedures and protocol compliance
• Ensure integrity of CRF and other data through source-document monitoring
• Monitor data for missing or implausible information
• Manage clinical registries and undertake feasibility work
• Complete SAE reporting, narratives, reports, and follow-up
• Perform CRF review and generate and resolve queries in Fortrea or client data-management systems
• Assist with training new employees through co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator
• Act as a local client contact when assigned
• Perform other duties assigned by management

Clinical Research Associate II, Phase I

• Provide a high standard of care for participants in clinical trials
• Respond to emergency situations based upon clinical research standards
• Perform routine monitoring and close-out of clinical sites
• Maintain study files
• Conduct pre-study and initiation visits
• Liaise with vendors
• Manage study sites according to project plans
• Ensure study staff receive proper materials and instructions
• Verify informed consent procedures and protocol requirements comply with applicable regulations
• Monitor source documents and verify the integrity of CRF and other collected data
• Manage clinical registries and undertake feasibility work
• Complete Serious Adverse Event reporting, narratives, reports, and follow-up
• Perform CRF review and generate and resolve queries in data management systems
• Assist with training new employees through co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator
• Act as a local client contact when assigned
• Perform other duties assigned by management

Associate

• Serve as primary contact with investigative sites during site start-up and maintenance activities
• Collect, organize, quality-review, format, compile, and track investigator and essential documents
• Ensure EC/IRB/Third body/Regulatory Authority and local applications are submitted within agreed timelines
• Provide guidance to sites and authorities regarding submission requirements
• Maintain awareness of regulatory legislation, guidance, practice, and current standards
• Serve as local expert for project start-up activities in an assigned country or region
• Prepare country application forms, cover letters, and routine regulatory submissions such as INDs/CTAs
• Liaise with regulatory authorities, internal teams, external vendors, and investigative sites
• Review final submission documents and ensure compliance with laws, guidelines, ICH/GCP, SOPs, and quality standards
• Track start-up and maintenance activities, milestones, timelines, budgets, and deliverables
• Prevent, identify, and escalate study issues and delivery risks
• Customize patient informed consent forms for local requirements and protocol compliance
• Support negotiation and tracking of site contracts and budgets when applicable
• Upload and monitor submission documentation, notifications, and alerts in CTIS for EU studies
• Participate in team and project meetings
• Mentor and train new hires and less-experienced colleagues when appropriate

Study Start-up Associate – Site Activation Specialist

Communications

• Develop and execute communication plans supporting business unit priorities, employee engagement, operational updates, and leadership visibility.
• Partner with business unit leaders and subject matter experts to understand communication needs, recommend approaches, and deliver accurate, timely content.
• Write, edit, and coordinate employee announcements, leader messages, talking points, newsletter content, intranet articles, presentations, video scripts, and Q&A materials.
• Translate complex business, operational, and functional information into clear, concise, audience-focused communications.
• Coordinate reviews, approvals, distribution timing, and channel execution with Corporate Communications, HR, Legal, and business stakeholders.
• Maintain business unit communication calendars, editorial plans, distribution lists, and message tracking.
• Gather feedback, review engagement data, and recommend improvements to content and channels.
• Apply Fortrea’s voice, tone, brand standards, and editorial guidelines.
• Handle sensitive or confidential information with discretion and escalate issues appropriately.
• Perform other duties as assigned.
• Travel up to 10% domestically or internationally; occasional drives to site locations.

Corporate Communications Manager

Clinical Operations

• Lead country-level Clinical Quality Management activities and quality improvement initiatives
• Ensure implementation and maintenance of global and local processes, SOPs, and regulatory requirements
• Oversee Quality Control activities, trend analysis, root cause investigations, and corrective action plans
• Act as the primary local contact for audits, inspections, and regulatory agency interactions
• Support training programs and partner with stakeholders to identify development needs
• Manage supplier quality qualification activities and support compliance and privacy initiatives
• Collaborate with cross-functional teams to drive operational excellence and quality outcomes
• Report to the Regional Director, Clinical Quality Management
• Drive quality and compliance across clinical trial operations while ensuring adherence to ICH-GCP, local regulations, and global processes

Clinical Research Associate II, Phase I

Clinical Research Associate II, Phase I

Study Start-up Associate – Site Activation Specialist

Corporate Communications Manager

Country Clinical Quality Manager